SIST EN ISO 14607:2009
(Main)Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO 14607:2007)
L'ISO 14607:2007 spécifie les exigences particulières relatives aux implants mammaires destinés à des fins cliniques.
En matière de sécurité, l'ISO 14607:2007 spécifie des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant.
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO 14607:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14607:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 14607:2007
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2007)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2007)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2007)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2007)
Ta slovenski standard je istoveten z: EN ISO 14607:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14607:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14607:2009
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SIST EN ISO 14607:2009
EUROPEAN STANDARD
EN ISO 14607
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 14607:2007
English Version
Non-active surgical implants - Mammary implants - Particular
requirements (ISO 14607:2007)
Implants chirurgicaux non actifs - Implants mammaires - Nichtaktive chirurgische Implantate - Mammaimplantate -
Exigences particulières (ISO 14607:2007) Besondere Anforderungen (ISO 14607:2007)
This European Standard was approved by CEN on 19 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2009: E
worldwide for CEN national Members.
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SIST EN ISO 14607:2009
EN ISO 14607:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 14607:2009
EN ISO 14607:2009 (E)
Foreword
The text of ISO 14607:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 14607:2009 by
Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14607:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 14607:2007 has been approved by CEN as a EN ISO 14607:2009 without any modification.
3
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SIST EN ISO 14607:2009
EN ISO 14607:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4 1 - 2 - 3 - 4 - 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 -
7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 -
8.2 - 9.2
7 1 - 2 - 3 - 4 - 5 - 6 - 6.a - 7.1 - 7.2
- 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
11 1 - 2 - 13 Subclause 11.7 requires that the
information detailed in Annex F
be given to the patient by the
medical staff, in accordance with
the Essential Requirements 13.6
k) and l).
The part of ER 13.3.a
concerning the information on
the authorized representative is
not addressed in this European
Standard
ER 13.6.q) This relevant
Essential Requirement is not
addressed in this European
Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
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SIST EN ISO 14607:2009
INTERNATIONAL ISO
STANDARD 14607
Second edition
2007-02-15
Non-active surgical implants — Mammary
implants — Particular requirements
Implants chirurgicaux non actifs — Implants mammaires — Exigences
particulières
Reference number
ISO 14607:2007(E)
©
ISO 2007
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
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Published in Switzerland
ii © ISO 2007 – All rights reserved
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Intended performance . 2
5 Design attributes. 2
6 Materials . 3
7 Design evaluation . 3
7.1 General. 3
7.2 Pre-clinical evaluation. 3
7.3 Clinical evaluation . 6
7.4 Post-market surveillance . 7
8 Manufacturing . 7
9 Sterilization. 7
10 Packaging . 7
11 Information supplied by the manufacturer .7
11.1 General. 7
11.2 Resterilization . 8
11.3 Base dimensions . 8
11.4 Effects on diagnostic techniques . 8
11.5 Filling materials. 8
11.6 Information on expected lifetime . 8
11.7 Information for the patient . 8
11.8 Labels. 9
11.9 Information for the user . 9
11.10 Marking on implants. 9
11.11 Manufacturer’s device card . 9
Annex A (normative) Test for surface characteristics . 10
Annex B (normative) Tests for shell integrity . 11
Annex C (normative) Test method for valve competence and injection site competence. 13
Annex D (normative) Test for silicone gel cohesion (silicone filling materials only) . 15
Annex E (normative) Mechanical tests on a mammary implant in its implantable state. 17
Annex F (normative) Information for the patient . 22
Annex G (normative) Information for the user . 24
Annex H (informative) Silicone release assessment from mammary implants by an in vitro
method . 25
Bibliography . 28
© ISO 2007 – All rights reserved iii
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14607 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 285, Non-active surgical implants, in collaboration with Technical Committee ISO/TC 150, Implants
for surgery, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
This second edition cancels and replaces the first edition (ISO 14607:2002), which has been technically
revised.
iv © ISO 2007 – All rights reserved
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
Introduction
In addition to the requirements given in the level 1 standard, this International Standard provides a method for
addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants.
It also provides a method to demonstrate compliance with the relevant Essential Requirements as outlined in
general terms in Annex I of the Directive 93/42/EEC of 14 June 1993 concerning medical devices (amended
by the Commission Directive 2003/12/CE), as they apply to mammary implants for use in clinical practice.
Further specific information on mammary implants indicating how to comply with the Directive 93/42/EEC is
given by the Communication from the European Commission on community and national measures in relation
to mammary implants.
There are three levels of European Standards dealing with non-active surgical implants. These are as follows
(with level 1 being highest):
⎯ Level 1: General requirements for non-active surgical implants;
⎯ Level 2: Particular requirements for families of non-active surgical implants;
⎯ Level 3: Specific requirements for types of non-active surgical implants.
This is a level 2 standard and contains particular requirements for a family of mammary implants.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It also
indicates that there are additional requirements in the level 2 and level 3 standards.
To address all requirements, it is necessary to start with a standard of the lowest available level.
© ISO 2007 – All rights reserved v
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SIST EN ISO 14607:2009
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SIST EN ISO 14607:2009
INTERNATIONAL STANDARD ISO 14607:2007(E)
Non-active surgical implants — Mammary implants — Particular
requirements
1 Scope
This International Standard specifies particular requirements for mammary implants for clinical practice.
With regard to safety, this International Standard specifies requirements for intended performance, design
attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by
the manufacturer.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies
ISO 34-1:2004, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser,
angle and crescent test pieces
ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General
requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
1)
ISO 14630:— , Non-active surgical implants — General requirements
NF S 99-401:1994, Medical devices — Silicone elastomer of medical grade
NOTE The Bibliography gives informative references to other useful standards.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 14155-1, ISO 14155-2
and ISO 14630 and the following apply.
3.1
anterior projection
maximum height of the implant when placed with its base on a flat horizontal surface at its nominal volume
1) To be published. (Revision of ISO 14630:2005)
© ISO 2007 – All rights reserved 1
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
3.2
base dimensions
length of the major axis and the length of the minor axis when the implant is placed with its base on a flat
horizontal surface at its nominal volume
3.3
diffusion
movement of material in and/or out of an implant through an intact shell
3.4
injection site
component designed to be penetrated by a needle to alter the volume of the implant
3.5
mammary implant
implant with a shell which is filled by the manufacturer or the surgeon and is designed to add to or replace
volume of the breast
3.6
orientation means
mark in or on the implant to assist the surgeon in positioning the implant
3.7
release
movement out of an implant of material originating from the filling material or the shell, or products resulting
from the interaction of the two
3.8
shell
envelope of the implant
3.9
seam
seal junction of materials fused or adhered together
3.10
valve
component of the shell into which an accessory is inserted to inflate variable volume implants
4 Intended performance
The requirements of ISO 14630:—, Clause 4, apply.
Specific attention shall be paid to ensure that the clinical condition and safety of the patient are not
compromised during the expected lifetime of the device under conditions of normal use.
NOTE 1 Information on expected duration of intended performances is given in 11.6.
NOTE 2 Information on the nature of the benefit expected from a mammary implant is given in 7.2.
NOTE 3 Information on specific risks related to the mammary implant is given in Clauses 5, 6 and 7.
5 Design attributes
The requirements of ISO 14630:—, Clause 5, apply.
2 © ISO 2007 – All rights reserved
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
In order to meet the intended performance requirements, the design attributes shall take into account the
ability to detect rupture.
The effect of ageing of materials shall be investigated.
6 Materials
The requirements of ISO 14630:—, Clause 6, apply.
In addition, if silicone elastomer is used, NF S 99-401:1994 applies.
Special attention shall be given to
⎯ biological evaluation of the device and its components following implant failure;
⎯ stability of the material (particularly filling material).
7 Design evaluation
7.1 General
The requirements of ISO 14630:—, 7.1, apply.
Mammary implants shall be designed and manufactured in such a way that, when used under the conditions
and for the purpose intended, they will not compromise the clinical condition, the safety or the health of the
patient. Any residual risks or undesirable side-effects that might be associated with their use shall constitute
acceptable risks when weighted against the benefits to the patient, taking into account the fact that their
benefit is deemed to be primarily aesthetic and psychological in nature, whether the application is for
reconstructive and/or cosmetic purposes.
Risk analysis and conformity evaluation shall be performed on the filler material, shell and mammary implant.
7.2 Pre-clinical evaluation
7.2.1 General
The pre-clinical evaluation of mammary implants shall conform to ISO 14630:—, 7.2.
Where no test is described in this International Standard, or when the test described is not applicable,
description for the alternative validated test method and sample preparation used shall be documented by the
manufacturer. The adequacy of the pass/fail criteria adopted for the evaluation shall be verified prior to testing.
All testing shall be performed on finished sterilised devices or components.
The sample size selected shall be based on a statistical rationale, which shall be justified and documented.
NOTE With regard to validated test methods available for the pre-clinical evaluation, this International Standard
reflects the present state of the art.
Where appropriate, for materials other than silicone, the manufacturer should consider and develop tests as
indicated in 7.2.2.
© ISO 2007 – All rights reserved 3
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
7.2.2 Mechanical tests
7.2.2.1 General
Mechanical tests shall be conducted in accordance with Annexes A, B, C, D and E and shall comply with the
stated requirements.
The goal of mechanical tests is to ensure a low rupture rate of the device under normal conditions of use.
7.2.2.2 Shell integrity
7.2.2.2.1 General
The integrity of the shell shall be evaluated.
The following properties of the silicone elastomer shell shall be tested in accordance with Annex B and shall
comply with the stated requirements. A worst-case assumption should be considered.
For materials other than silicone elastomer, relevant tests shall be developed.
7.2.2.2.2 Elongation
The elongation of the silicone elastomer shell shall be tested in accordance with B.1 and shall comply with the
stated requirements.
7.2.2.2.3 Tear resistance
The tear resistance shall be tested in accordance with B.1.
7.2.2.2.4 Strength of joints, seams or seals
The resistance to failure of joints, seams and seals shall be tested in accordance with B.2 and shall comply
with the stated requirements.
7.2.2.2.5 Design of shell
Care shall be taken when selecting materials to be used in the manufacture of the shell. Surfaces both inside
and outside the shell shall be suitable to minimize or prevent frictional abrasion both between shell-to-shell
surface and between shell surface and the implantation site. If such frictional abrasion is likely to be a
significant problem, the manufacturer shall indicate any relevant tests carried out to ensure the suitability of
the shell when implanted.
7.2.2.3 Valve or injection site competence
The competence of the valve or injection site shall be tested in accordance with Annex C and shall comply
with the stated requirements.
7.2.2.4 Filling material
7.2.2.4.1 General
The physical compatibility between the filling material and the shell shall be demonstrated by providing long-
term data on shell performance and integrity.
4 © ISO 2007 – All rights reserved
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
7.2.2.4.2 Test for silicone gel cohesion
If silicone gel is used as filling material, cohesivity testing shall be performed to measure both the rheological
properties and the integrity of the gel in accordance with Annex D and shall comply with the stated
requirements in order to optimize clinical performance and safety.
For filling materials other than silicone gel, an appropriate and validated test for cohesivity shall be used.
7.2.2.5 Implant resistance
7.2.2.5.1 General
Static rupture resistance testing, fatigue resistance testing and impact resistance testing shall be conducted in
accordance with Annex E and shall comply with the stated requirements.
7.2.2.5.2 Fatigue resistance test
The fatigue resistance test shall be conducted in accordance with E.1. After testing, the shell of the implant
shall not present any tears, cracks or cuts when examined under × 10 magnification.
7.2.2.5.3 Impact resistance test
The impact resistance test shall be conducted in accordance with E.2 and shall comply with the stated
requirements.
7.2.2.5.4 Static rupture resistance test
The static rupture resistance test shall be performed in accordance with E.3 and the test results shall be
recorded.
7.2.2.6 Volume
The volume of prefilled implants shall be within ± 2,5 % of the volume stated on the packaging (see 11.3).
Volume shall be expressed in SI units.
7.2.2.7 Dimensions
The intended design base dimensions and anterior projection and their tolerances shall be recorded.
7.2.2.8 Surface
If the surface is specially treated or processed in order to form a specific texture, the surface characteristics
shall be tested in accordance with Annex A and the test results shall be recorded.
7.2.3 Chemical evaluation
7.2.3.1 General
Shell and filler materials shall be chemically evaluated.
7.2.3.2 Shell material, silicone elastomer or coated materials
An analysis of the extractable or releasable chemicals (especially the characterization and quantification of
materials of low molecular mass) is necessary to assess the safety of the device.
© ISO 2007 – All rights reserved 5
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SIST EN ISO 14607:2009
ISO 14607:2007(E)
7.2.3.3 Filler materials
A detailed chemical characterization of the filler material shall be established.
Long-term stability data, established under physiological conditions, and accelerated ageing studies shall be
provided to demonstrate the effects of time and temperature on the physical and chemical characteristics of
the device.
7.2.3.4 Release test
Release from the whole implant shall be evaluated.
NOTE 1 No validated test method is currently available. For implants with a silicone shell and silicone filling, it is not
clear which proportion of the release comes from the shell or the filler material respectively. The test methods and
requirements for this clause are under consideration.
NOTE 2 There are currently two test methods available that might provide some valuable information concerning the
release: the ASTM F 703-96 and the release test described in Annex H.
7.2.4 Biological evaluation
The implant shall be evaluated for
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO 14607:2007)Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007)Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO 14607:2007)Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:prEN ISO 14607kSIST prEN ISO 14607:2009en01-marec-2009kSIST prEN ISO 14607:2009SLOVENSKI
STANDARD
kSIST prEN ISO 14607:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 14607December 2008ICS 11.040.40Will supersede EN ISO 14607:2007
English VersionNon-active surgical implants - Mammary implants - Particularrequirements (ISO 14607:2007)Implants chirurgicaux non actifs - Implants mammaires -Exigences particulières (ISO 14607:2007)Nichtaktive chirurgische Implantate - Mammaimplantate -Besondere Anforderungen (ISO 14607:2007)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 285.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 14607:2008: EkSIST prEN ISO 14607:2009
prEN ISO 14607:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 14607:2009
prEN ISO 14607:2008 (E) 3 Foreword The text of ISO 14607:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as prEN ISO 14607:2008 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 14607:2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 14607:2007 has been approved by CEN as a prEN ISO 14607:2008 without any modification. kSIST prEN ISO 14607:2009
prEN ISO 14607:2008 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA — Correspondence between this
European
Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4 1 - 2 - 3 - 4 - 7.1
5 1 - 2 - 3 -4 -5 -7.1 -7.2 -7.3 -7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 -7.2 -7.3 -7.4 -7.5 -8.2 - 9.2
7 1 - 2 - 3 - 4 - 5 - 6 - 6.a - 7.1 - 7.2 - 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
kSIST prEN ISO 14607:2009
prEN ISO 14607:2008 (E) 5
11 1 - 2 - 13 Subclause 11.7 requires that the information detailed in Annex F be given to the patient by the medical staff, in accordance with the Essential Requirements 13.6 k) and l).
The part of ER 13.3.a concerning the information on the authorized representative is not addressed in this European Standard
ER 13.6.q) This relevant Essential Requirement is not addressed in this European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
kSIST prEN ISO 14607:2009
kSIST prEN ISO 14607:2009
Reference numberISO 14607:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO14607Second edition2007-02-15Non-active surgical implants — Mammary implants — Particular requirements Implants chirurgicaux non actifs — Implants mammaires — Exigences particulières
kSIST prEN ISO 14607:2009
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ii © ISO 2007 – All rights reserved
kSIST prEN ISO 14607:2009
ISO 14607:2007(E) © ISO 2007 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.1 4 Intended performance.2 5 Design attributes.2 6 Materials.3 7 Design evaluation.3 7.1 General.3 7.2 Pre-clinical evaluation.3 7.3 Clinical evaluation.6 7.4 Post-market surveillance.7 8 Manufacturing.7 9 Sterilization.7 10 Packaging.7 11 Information supplied by the manufacturer.7 11.1 General.7 11.2 Resterilization.8 11.3 Base dimensions.8 11.4 Effects on diagnostic techniques.8 11.5 Filling materials.8 11.6 Information on expected lifetime.8 11.7 Information for the patient.8 11.8 Labels.9 11.9 Information for the user.9 11.10 Marking on implants.9 11.11 Manufacturer’s device card.9 Annex A (normative)
Test for surface characteristics.10 Annex B (normative)
Tests for shell integrity.11 Annex C (normative)
Test method for valve competence and injection site competence.13 Annex D (normative)
Test for silicone gel cohesion (silicone filling materials only).15 Annex E (normative)
Mechanical tests on a mammary implant in its implantable state.17 Annex F (normative)
Information for the patient.22 Annex G (normative)
Information for the user.24 Annex H (informative)
Silicone release assessment from mammary implants by an in vitro method.25 Bibliography.28
kSIST prEN ISO 14607:2009
ISO 14607:2007(E) iv © ISO 2007 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14607 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in collaboration with Technical Committee ISO/TC 150, Implants for surgery, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). This second edition cancels and replaces the first edition (ISO 14607:2002), which has been technically revised. kSIST prEN ISO 14607:2009
ISO 14607:2007(E) © ISO 2007 – All rights reserved vIntroduction In addition to the requirements given in the level 1 standard, this International Standard provides a method for addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate compliance with the relevant Essential Requirements as outlined in general terms in Annex I of the Directive 93/42/EEC of 14 June 1993 concerning medical devices (amended by the Commission Directive 2003/12/CE), as they apply to mammary implants for use in clinical practice. Further specific information on mammary implants indicating how to comply with the Directive 93/42/EEC is given by the Communication from the European Commission on community and national measures in relation to mammary implants. There are three levels of European Standards dealing with non-active surgical implants. These are as follows (with level 1 being highest): ⎯ Level 1: General requirements for non-active surgical implants; ⎯ Level 2: Particular requirements for families of non-active surgical implants; ⎯ Level 3: Specific requirements for types of non-active surgical implants. This is a level 2 standard and contains particular requirements for a family of mammary implants. The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. To address all requirements, it is necessary to start with a standard of the lowest available level.
kSIST prEN ISO 14607:2009
kSIST prEN ISO 14607:2009
INTERNATIONAL STANDARD ISO 14607:2007(E) © ISO 2007 – All rights reserved 1Non-active surgical implants — Mammary implants — Particular requirements 1 Scope This International Standard specifies particular requirements for mammary implants for clinical practice. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies ISO 34-1:2004, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces ISO 37, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General requirements ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans ISO 14630:—1), Non-active surgical implants — General requirements NF S 99-401:1994, Medical devices — Silicone elastomer of medical grade NOTE The Bibliography gives informative references to other useful standards. 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 14155-1, ISO 14155-2 and ISO 14630 and the following apply. 3.1 anterior projection maximum height of the implant when placed with its base on a flat horizontal surface at its nominal volume
1) To be published. (Revision of ISO 14630:2005) kSIST prEN ISO 14607:2009
ISO 14607:2007(E) 2 © ISO 2007 – All rights reserved 3.2 base dimensions length of the major axis and the length of the minor axis when the implant is placed with its base on a flat horizontal surface at its nominal volume 3.3 diffusion movement of material in and/or out of an implant through an intact shell 3.4 injection site component designed to be penetrated by a needle to alter the volume of the implant 3.5 mammary implant implant with a shell which is filled by the manufacturer or the surgeon and is designed to add to or replace volume of the breast 3.6 orientation means mark in or on the implant to assist the surgeon in positioning the implant 3.7 release movement out of an implant of material originating from the filling material or the shell, or products resulting from the interaction of the two 3.8 shell envelope of the implant 3.9 seam seal junction of materials fused or adhered together 3.10 valve component of the shell into which an accessory is inserted to inflate variable volume implants 4 Intended performance The requirements of ISO 14630:—, Clause 4, apply. Specific attention shall be paid to ensure that the clinical condition and safety of the patient are not compromised during the expected lifetime of the device under conditions of normal use. NOTE 1 Information on expected duration of intended performances is given in 11.6. NOTE 2 Information on the nature of the benefit expected from a mammary implant is given in 7.2. NOTE 3 Information on specific risks related to the mammary implant is given in Clauses 5, 6 and 7. 5 Design attributes The requirements of ISO 14630:—, Clause 5, apply. kSIST prEN ISO 14607:2009
ISO 14607:2007(E) © ISO 2007 – All rights reserved 3In order to meet the intended performance requirements, the design attributes shall take into account the ability to detect rupture. The effect of ageing of materials shall be investigated. 6 Materials The requirements of ISO 14630:—, Clause 6, apply. In addition, if silicone elastomer is used, NF S 99-401:1994 applies. Special attention shall be given to ⎯ biological evaluation of the device and its components following implant failure; ⎯ stability of the material (particularly filling material). 7 Design evaluation 7.1 General The requirements of ISO 14630:—, 7.1, apply. Mammary implants shall be designed and manufactured in such a way that, when used under the conditions and for the purpose intended, they will not compromise the clinical condition, the safety or the health of the patient. Any residual risks or undesirable side-effects that might be associated with their use shall constitute acceptable risks when weighted against the benefits to the patient, taking into account the fact that their benefit is deemed to be primarily aesthetic and psychological in nature, whether the application is for reconstructive and/or cosmetic purposes. Risk analysis and conformity evaluation shall be performed on the filler material, shell and mammary implant. 7.2 Pre-clinical evaluation 7.2.1 General The pre-clinical evaluation of mammary implants shall conform to ISO 14630:—, 7.2. Where no test is described in this International Standard, or when the test described is not applicable, description for the alternative validated test method and sample preparation used shall be documented by the manufacturer. The adequacy of the pass/fail criteria adopted for the evaluation shall be verified prior to testing. All testing shall be performed on finished sterilised devices or components. The sample size selected shall be based on a statistical rationale, which shall be justified and documented. NOTE With regard to validated test methods available for the pre-clinical evaluation, this International Standard reflects the present state of the art. Where appropriate, for materials other than silicone, the manufacturer should consider and develop tests as indicated in 7.2.2. kSIST prEN ISO 14607:2009
ISO 14607:2007(E) 4 © ISO 2007 – All rights reserved 7.2.2 Mechanical tests 7.2.2.1 General Mechanical tests shall be conducted in accordance with Annexes A, B, C, D and E and shall comply with the stated requirements. The goal of mechanical tests is to ensure a low rupture rate of the device under normal conditions of use. 7.2.2.2 Shell integrity 7.2.2.2.1 General The integrity of the shell shall be evaluated. The following properties of the silicone elastomer shell shall be tested in accordance with Annex B and shall comply with the stated requirements. A worst-case assumption should be considered. For materials other than silicone elastomer, relevant tests shall be developed. 7.2.2.2.2 Elongation The elongation of the silicone elastomer shell shall be tested in accordance with B.1 and shall comply with the stated requirements. 7.2.2.2.3 Tear resistance The tear resistance shall be tested in accordance with B.1. 7.2.2.2.4 Strength of joints, seams or seals The resistance to failure of joints, seams and seals shall be tested in accordance with B.2 and shall comply with the stated requirements. 7.2.2.2.5 Design of shell Care shall be taken when selecting materials to be used in the manufacture of the shell. Surfaces both inside and outside the shell shall be suitable to minimize or prevent frictional abrasion both between shell-to-shell surface and between shell surface and the implantation site. If such frictional abrasion is likely to be a significant problem, the manufacturer shall indicate any relevant tests carried out to ensure the suitability of the shell when implanted. 7.2.2.3 Valve or injection site competence The competence of the valve or injection site shall be tested in accordance with Annex C and shall comply with the stated requirements. 7.2.2.4 Filling material 7.2.2.4.1 General The physical compatibility between the filling material and the shell shall be demonstrated by providing long-term data on shell performance and integrity. kSIST prEN ISO 14607:2009
ISO 14607:2007(E) © ISO 2007 – All rights reserved 57.2.2.4.2 Test for silicone gel cohesion If silicone gel is used as filling material, cohesivity testing shall be performed to measure both the rheological properties and the integrity of the gel in accordance with Annex D and shall comply with the stated requirements in order to optimize clinical performance and safety. For filling materials other than silicone gel, an appropriate and validated test for cohesivity shall be used. 7.2.2.5 Implant resistance 7.2.2.5.1 General Static rupture resistance testing, fatigue resistance testing and impact resistance testing shall be conducted in accordance with Annex E and shall comply with the stated requirements. 7.2.2.5.2 Fatigue resistance test The fatigue resistance test shall be conducted in accordance with E.1. After testing, the shell of the implant shall not present any tears, cracks or cuts when examined under × 10 magnification. 7.2.2.5.3 Impact resistance test The impact resistance test shall be conducted in accordance with E.2 and shall comply with the stated requirements. 7.2.2.5.4 Static rupture resistance test The static rupture resistance test shall be performed in accordance with E.3 and the test results shall be recorded. 7.2.2.6 Volume The volume of prefilled implants shall be within ± 2,5 % of the volume stated on the packaging (see 11.3). Volume shall be expressed in SI units. 7.2.2.7 Dimensions The intended design base dimensions and anterior projection and their tolerances shall be recorded. 7.2.2.8 Surface If the surface is specially treated or processed in order to form a specific texture, the surface characteristics shall be tested in accordance with Annex A and the test results shall be recorded. 7.2.3 Chemical evaluation 7.2.3.1 General Shell and filler materials shall be chemically evaluated. 7.2.3.2 Shell material, silicone elastomer or coated materials An analysis of the extractable or releasable chemicals (especially the characterization and quantification of materials of low molecular mass) is necessary to assess the safety of the device. kSIST prEN ISO 14607:2009
ISO 14607:2007(E) 6 © ISO 2007 – All rights reserved 7.2.3.3 Filler materials A detailed chemical characterization of the filler material shall be established. Long-term stability data, established under physiological conditions, and accelerated ageing studies shall be provided to demonstrate the effects of time and temperature on the physical and chemical characteristics of the device. 7.2.3.4 Release test Release from the whole implant shall be evaluated. NOTE 1 No validated test method is currently available. For implants with a silicone shell and silicone filling, it is not clear which proportion of the release comes from the shell or the filler material respectively. The test methods and requirements for this clause are under consideration. NOTE 2 There are currently two test methods available that might provide some valuable information concerning the release: the ASTM F 703-96 and the release test described in Annex H. 7.2.4 Biological evaluation The implant shall be evaluated for biological safety in accordance with the requirements of ISO 10993-1. The local and systemic toxicity of any substance introduced into the body by mammary implants shall be assessed. The toxicological evaluation shall be based on the chemical characterization and toxicokinetics of the materials, available scientific data addressing toxicological hazards and risks and, where necessary, specific testing. The evaluation shall address the potential for short-term and long-term effects, including cytotoxicity, irritation, haemocompatibility, genotoxicity, implantation, immunotoxicity and other forms of systemic toxicity, reproductive toxicity and carcinogenicity. Moreover, the effects of shell surface texture on surrounding tissues shall be evaluated. This evaluation shall be taken into account in the risk analysis. Knowledge of the toxicokinetics of potentially toxic or reactive ingredients or degradation products is necessary when these could be released into the body in substantial quantities following implantation. Information on distribution, transformation and elimination, applicable to the route of exposure, is therefore necessary. The manufacturer shall determine and justify if in vivo tests are necessary or not. NOTE Evaluation might include a study of relevant experience and/or actual testing. This kind of evaluation might conclude that no testing is needed if the implant material, manufactured in the same way, has a demonstrable history of use in a specified role that is equivalent to that of the device under design (ISO 10993-1:2003, Clause 6). 7.3 Clinical evaluation The requirements of ISO 14630:—, 7.3, apply. In the case of clinical investigation, the requirements of ISO 14155-1 and ISO 14155-2 apply. NOTE Additional information on literature review is provided in ISO 14155-1:2003, Annex A. The purpose of the clinical evaluation is to estimate the frequency and rate at which local complications occur, in particular capsular contracture and ruptures/deflation of implants, after a correct implantation of a mammary implant. The criteria for acceptance (i.e. safety and effectiveness
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